レギュラトリーアフェアーズマネージャー/ Regulatory Affairs Manager

An international veterinary pharmaceutical company is looking for a Regulatory Affairs Manager. The selected candidate will oversee regulatory strategy, product compliance, quality systems, pharmacovigilance, and external affairs to ensure business continuity and legal adherence.

Responsibilities:

• Develop and execute regulatory strategies for new submissions and product lifecycle management
• Manage regulatory submissions, approvals, and interactions with authorities
• Oversee affiliate quality systems and ensure compliance with corporate and local requirements
• Lead pharmacovigilance activities, ensure local compliance, and liaise with global procedures
• Represent the company in public affairs, maintaining networks with authorities and industry groups
• Maintain regulatory records and ensure timely documentation and archive management
• Supervise local product studies and manage label and packaging approvals
• Monitor legislative changes and regulatory trends in the animal health industry

Requirements:

• Bachelor’s degree or above in Life Sciences, Veterinary Medicine, Pharmacy, or a related field
• Several years of experience in regulatory affairs within the veterinary pharmaceutical industry
• Experience managing regulatory submissions, registrations, and compliance
• Strong knowledge of veterinary pharmaceutical regulatory requirements and guidelines
• Excellent project management and stakeholder communication skills

About the Company:

A global leader in animal health, this innovative company combines advanced science with tailored solutions to protect and enhance the lives of animals and those who care for them. With a strong presence in Japan and worldwide, it offers a dynamic environment for job hunters passionate about veterinary science, biotechnology, and sustainable healthcare.

Keywords:

規制遵守, 獣医用医薬品, 規制事務, 品質保証, 薬物監視, 公共関係, 製品ライフサイクル管理, 規制戦略, 当局とのコミュニケーション, 品質システム, 求人, 外資系

Job Ref: 37EA7N